Every week, more than a thousand patients are killed in American hospitals as a result of negligence.

FDA is no longer able to make the kinds of demands for scientific information and validation of safety that they used to, on people who are selling food supplements,

There’s this halo, sacrosanct idea of gene therapy, that no one could be involved unless they’re completely trustworthy, that maybe left more blinders on than in other areas.

To put out a guideline that reiterates existing law and regulations is a stunt.

be able to get away with twisting the truth a little bit, enough to convince patients to go to their doctors [and] to convince their doctors to prescribe the drug.

Your committees need to reject this desperate attempt to revive this barely effective drug.

[Sen. Chuck Grassley, R-Iowa, was less impressed, saying in a statement that the guidelines failed to deliver] a single guarantee for consumers. … nothing that really is meaningful.

There’s no unique evidence of any benefit, and there’s still persistent evidence of risk.

They (the guidelines) are designed as a desperate attempt to fend off real regulation of drug ads.

It is an extremely dangerous drug, and it’s just reckless for any company to be selling it, and it’s reckless in the extreme for the FDA to allow this to stay on the market.

I’ve always been concerned about this dangerously cozy relationship between the joint commission and the hospital industry generally, and the individual hospitals that it looks at,

Advertising of prescription drugs is too important to be left to industry themselves,

The accidental deaths are people who are taking the drug for a very long period of time. These are people who are at, or slightly higher than, the recommended dose. The NPX lasts longer in...

It’s one of the leading causes of drug-related deaths. And it has almost no benefit. It is a very lousy painkiller.

States can do as little or as much as they want.

They’re in the middle, but the middle isn’t good enough.

It’s really a kick in the head to the secrecy surrounding the National Practitioners’ Databank that states are taking this matter into their own hands.

A critical part of improving the system for drug safety is remembering, admitting and learning from past mistakes.

They’re basically saying ‘just keep selling it off.’ … They admit that it’s uniquely dangerous… yet they’re just letting it sit here.

If the FDA approves this drug, it is certain that it will have to be banned within a short time after marketing begins because of the high probability of further occurrence of the serious injuries...

They are kinder and gentler to the industry than the Office of Drug Safety has traditionally wanted to be. I don’t see this changing.

It is the Food and Drug Administration’s job to immediately and coherently tell consumers about the risks associated with the drugs they put into their bodies, … The agency has once again failed in this...

He’s a very smart guy, but he’s basically carrying out the agenda of the pharmaceutical industry. His bill completely immunizes the drug industry from lawsuits.

Hopefully the FDA will learn something from this,